The Eurpoean Medicines Agency (EMA) is investigating a number of fatalities that followed closely after administration of the Gilenya medication (a drug for treatment of multiple sclerosis).
Following a report of a fatality in the USA shortly after an initial administering of the drug, and six other unexplained deaths, the EMA decided to take this precaution and to publicize guidelines until the investigation is concluded.
Guidelines for Medical Teams will be Published within the Circular of the Medial Administration:
- Prior to deciding to start treatment with the drug, an ECG test must be performed.
- After initial treatment with the drug, the patient must remain under ECG observation for 6 hours.
- After initial treatment with the drug, the patient’s blood pressure and heartbeat must be checked once an hour for 6 hours.
- If the patient develops cardiac symptoms (such as bradycardia or block-AV), extension of the observation period must be considered.
Guidelines for Patients:
- Report any cariac problems immediately to your physician, for example - chest pains, weakness or dizziness.
- Contact the care giving doctor or pharmacist with any question you may have.
The medication has been added to the medication basked as of January 2012.